Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise


Book Description

The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.




The Public Health Emergency Medical Countermeasures Enterprise


Book Description

During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)-a partnership among federal, state, and local governments; industry; and academia-is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.










The Public Health Emergency Medical Countermeasures Enterprise Review


Book Description

The MCM (medical countermeasure) enterprise exists to develop, manufacture, procure, stockpile, and eventually distribute products deemed critical to protecting or treating our population against a variety of naturally occurring or intentionally delivered CBRN threats. However, this MCM enterprise does not exist in a vacuum. It is part of a complex, multi-component system of capabilities necessary to protect our country from a wide range of health threats. This document was prepared in response to the Secretary's request for a review of the MCM development enterprise. HHS recognizes that there are multiple components and organizations essential to the timely development, deployment, and use of MCMs, including critical investment in the Nation's public health system. Indeed, absent the means to detect a health threat or distribute and administer an MCM, investments in the development and manufacturing of MCMs are of limited value. While recognizing these important dependencies, this review is limited to that part of the MCM enterprise that focuses specifically on the processes, policies, and infrastructure required to take a product concept derived from a national requirement through research, early and advanced development, manufacturing, regulatory approval, procurement, and sustained stockpiling. A larger framing of the public health infrastructure needs for national health security is described in the NHSS (National Health Security Strategy).




Dispensing Medical Countermeasures for Public Health Emergencies


Book Description

On March 3-4, 2008, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted a workshop titled "Medical Countermeasures Dispensing." The overall objective was to discuss a range of solutions to rapidly provide medical countermeasures to protect large numbers of people prior to or during a public health emergency, such as a bioterrorist attack or infectious disease outbreak. The United States is currently unprepared to confront the range of threats it is facing, such as an intentional anthrax release, severe acute respiratory syndrome (SARS), or pandemic influenza, and it must plan aggressively to counteract the threat of these and other future public health emergencies. Countermeasure dispensing must harness all types of imaginative partnerships between public and private institutions, working together in ways tailored to meet individual community needs. This workshop summary highlights the presentations and subsequent discussion that occurred at the workshop.







Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency


Book Description

During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication. As part of the United States' scientific and research preparedness enterprise, there is an imperative to go "beyond the last mile" of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6â€"7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.




Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan


Book Description

The United States continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical, biological, radiological, and nuclear (CBRN) agents, as well as from naturally occurring and emerging infectious diseases, including pandemic influenza. This book looks at how the United States has planned and implemented for these threats.




The Nation's Medical Countermeasure Stockpile


Book Description

Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction's medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions' resources. The Centers for Disease Control and Prevention's (CDC's) Strategic National Stockpile (SNS) is the nation's repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response's (OPHPR's) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation's health. The National Academies of Sciences, Engineering, and Medicine organized a two-day public workshop to explore opportunities to improve the efficiency, effectiveness, and sustainable methods used by the CDC's SNS to distribute medical countermeasures and other supplies during disasters and other public health emergencies, especially those which result in disruption of physical infrastructure such as the electrical grid, central roadways, bridges, and tunnels within the impacted community. Participants explored relevant distribution lessons learned from other federal agency stockpiles and the private sector as well as opportunities to develop public-private collaborations in the purchase, warehousing, management, and distribution of medical countermeasures. This report summarizes the presentations and discussions from the workshop.